FDA Approvals

Cheaper hep C drug enters competitive market
Cheaper hep C drug enters competitive marketA new drug approved by FDA to treat chronic hepatitis C virus (HCV) infection this week enters a competitive, lucrative market headed up by Gilead Science’s Sovaldi and Harvoni, as well as AbbVie’s Viekira Pak. FDA granted priority review and breakthrough therapy designation to Gilead’s combination product, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg).
Zika vaccine on the horizonThe U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
FDA approves rare liver disease drugFDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA approves first treatment for acute GVHDFDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
FDA approves novel kidney disease drugAfter initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline. Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
First US cholera vaccine availableFDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
Teva halts migraine patch sales over burnsTeva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.
New hypertension drug gets FDA approvalThe first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.
FDA approves Zinbryta to treat multiple sclerosisFDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).
First 4-strain flu vaccine availableFDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.